NCT01060358

Brief Summary

The purpose of this study is to verify the existence of neuromuscular neutral zones(NNZs) in humans, and develop non-invasive techniques to measure intervertebral kinematics of the lumbar spine. The results will be used to accurately quantify NNZs in humans, and provide a foundation for clinical trials on low back pain patients using this methodology.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Aug 2009

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2009

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

January 29, 2010

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 2, 2010

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2011

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2011

Completed
Last Updated

February 7, 2013

Status Verified

January 1, 2010

Enrollment Period

1.7 years

First QC Date

January 29, 2010

Last Update Submit

February 5, 2013

Conditions

Spine StabilityLow Back Pain

Keywords

lumbar spinelow back pain

Outcome Measures

Primary Outcomes (1)

  • neuromuscular neutral zones

    one year

Study Arms (1)

healthy

Healthy and active men and women between 21 and 45 years old with no history of low back pain or low back injury.

Procedure: method (non-surgical) to measure neuromuscular neutral zones

Interventions

method (non-surgical) to measure neuromuscular neutral zonesPROCEDURE
healthy

Eligibility Criteria

Age21 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

Healty men and women between 21 and 45 years old with no history of low back pain of low back injury.

You may qualify if:

  • years of age - typical working age in physically demanding jobs
  • no history of low back injury or musculoskeletal disorder in the past one year
  • any activity history: sedentary, active, or non-athletic, and 4) any ethnic background or race
  • body mass index score less than 30

You may not qualify if:

  • Younger than 21 or older than 45 years old (range not relevant to majority of physical labor force)
  • previous injury, disorder, or illness related to the low back
  • professional athletes
  • professional workers engaged in physical labor (e.g., roofers, loaders/unloaders in warehouses, tile/concrete layers, etc.)
  • pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Colorado Denver

Aurora, Colorado, 80045, United States

Location

MeSH Terms

Conditions

Low Back Pain

Interventions

Methods

Condition Hierarchy (Ancestors)

Back PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

  • Bradley Davidson, Ph.D.

    University of Colorado, Denver

    PRINCIPAL INVESTIGATOR

  • Moshe Solomonow, Ph.D., M.D. (hon)

    University of Colorado, Denver

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 29, 2010

First Posted

February 2, 2010

Study Start

August 1, 2009

Primary Completion

May 1, 2011

Study Completion

November 1, 2011

Last Updated

February 7, 2013

Record last verified: 2010-01

Locations

US(1)